Effect of Empirical Left Atrial Appendage Isolation on Long-term Procedure Outcome in Patients With Persistent or Long-standing Persistent Atrial Fibrillation Undergoing Catheter Ablation (BELIEF)

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2011 by Texas Cardiac Arrhythmia Research Foundation
Sponsor:
Information provided by (Responsible Party):
Andrea Natale, Texas Cardiac Arrhythmia Research Foundation
ClinicalTrials.gov Identifier:
NCT01362738
First received: May 26, 2011
Last updated: June 4, 2013
Last verified: May 2011
  Purpose

The purpose of this prospective randomized study is to assess whether empirical Left Atrial Appendage (LAA) isolation along with the standard approach of pulmonary vein isolation (PVI) and ablation of extra-pulmonary triggers is superior to the standard approach alone in enhancing the long-term success rate of catheter ablation in persistent or long-standing persistent atrial fibrillation (AF) patients.


Condition Intervention Phase
Persistent Atrial Fibrillation
Procedure: RFCA of PV and extra-PV triggers
Procedure: LAA isolation along with the conventional ablation strategy
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Effect of Empirical Left Atrial Appendage Isolation on Long-term Procedure Outcome in Patients With Persistent or Long-standing Persistent Atrial Fibrillation Undergoing Catheter Ablation

Resource links provided by NLM:


Further study details as provided by Texas Cardiac Arrhythmia Research Foundation:

Primary Outcome Measures:
  • Freedom from AF/ATs [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
    Freedom from AF/ATs, defined as no episodes of AF/AT without AADs lasting >30 seconds at follow-up


Secondary Outcome Measures:
  • Severe adverse events due to cardiac cause [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
    Severe adverse events (hospital admissions or death due to a cardiac cause)


Estimated Enrollment: 156
Study Start Date: November 2010
Estimated Study Completion Date: July 2015
Estimated Primary Completion Date: July 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Ablation of PV and extra-PV triggers
Conventional approach which includes pulmonary vein isolation (PVI) and ablation of extra-pulmonary triggers
Procedure: RFCA of PV and extra-PV triggers
PVAI and isolation of extra PV triggers
Active Comparator: LAA isolation along with the conventional ablation strategy
LAA isolation along with the conventional ablation strategy
Procedure: LAA isolation along with the conventional ablation strategy
PVAI + isolation of extra PV triggers + LAA isolation

Detailed Description:

Persistent (PeAF) and long-standing persistent (LSP) AF are defined as sustained AFs extending beyond seven days and one year respectively (1). Hypertensive, ischemic, valvular and other structural heart diseases most commonly underlie these arrhythmias (2) and the resulting abnormal atrial substrate is believed to be the major contributor toward perpetuation of AF in these non-paroxysmal categories. Several studies have demonstrated that pulmonary vein isolation (PVI) by radiofrequency catheter ablation (RFCA) though successfully restores sinus rhythm in most patients with paroxysmal AF; it has limited success in these sustained arrhythmias (3). Presence of potential trigger-generating areas in the left and right atrium besides pulmonary veins, with reported incidence from 3.2% to 47% (4), can be held responsible for this limited success. These areas include superior vena cava, ligament of Marshall, crista terminalis, coronary sinus, left atrial (LA) posterior wall and LA appendage (3). Therefore, in order to enhance the procedural-success rate, various hybrid measures have emerged to target the PV as well as extra-PV areas that have the ability to initiate or maintain AF. Several previous studies have demonstrated the prevalence of LAA firing in patients with recurrence of AF/AT (atrial tachycardia) after catheter ablation of AF (4). Embryologically, LAA is the remnant of primitive LA, which is formed by the adsorption of primordial PV and their branches during 4th week of embryonic development. Therefore, it is logical to suggest that LAA may initiate AF like pulmonary veins. In an earlier study conducted by our group on 987 AF patients, LAA firing was revealed to be the source of AF in 27% of patients and 93% of those patients were arrhythmia free 6 months after LAA isolation (4).

Our study aims to compare the procedure outcome for two different ablation strategies; 1) standard approach of pulmonary vein isolation extended to the posterior wall down to the coronary sinus and to the left side of the interatrial septum along with isolation of superior vena cava and ablation of complex fractionated atrial electrograms (CFAE) in the atria and coronary sinus, 2) standard approach plus LAA isolation.

Hypothesis: LAA isolation combined with standard ablation procedure enhances the procedural success rate in non-paroxysmal AF patients undergoing catheter ablation.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. 18-75 years
  2. History of PeAF or LSP AF refractory to antiarrhythmic drugs
  3. Willing and ability to understand and sign an informed consent

Exclusion Criteria:

  1. Reversible causes of AF (hyperthyroidism)
  2. Left atrial thrombus
  3. Moderate to severe valvular heart disease
  4. Contraindication for anticoagulation
  5. Life expectancy < 12 months
  6. Pregnancy
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01362738

Contacts
Contact: Luigi Di Biase, MD 512-423-9855 dibbia@gmail.com

Locations
United States, Texas
Texas Cardiac Arrhythmia Research Foundation Recruiting
Austin, Texas, United States, 78705
Contact: Luigi Di Biase, MD PhD    512-544-8186      
Principal Investigator: Luigi Di Biase, MD         
Principal Investigator: Andrea Natale, MD, FACC, FESC, FHRS         
St. David's Medical Center Recruiting
Austin, Texas, United States, 78705
Contact: Luigi Di Biase, MD PhD    512-544-8186      
Sponsors and Collaborators
Texas Cardiac Arrhythmia Research Foundation
  More Information

No publications provided

Responsible Party: Andrea Natale, Medical Director, Texas Cardiac Arrhythmia Research Foundation
ClinicalTrials.gov Identifier: NCT01362738     History of Changes
Other Study ID Numbers: TCAI_BELIEF
Study First Received: May 26, 2011
Last Updated: June 4, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Texas Cardiac Arrhythmia Research Foundation:
Long-standing persistent atrial fibrillation

Additional relevant MeSH terms:
Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on August 18, 2014